Defined as a reduction from Baseline in the complete Mayo score of ≥ 3 points and ≥ 30%, and a reduction from Baseline in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of ≤ 1 point

The CDAI is a composite score that is used to measure the clinical activity of Crohn's disease (CD). The CDAI uses a questionnaire with 8 disease activity variables: number of soft/liquid stools, severity of abdominal pain, general well-being, presence of complications, need for antidiarrheal drugs, presence of an abdominal mass, hematocrit, and deviation in body weight. The sub scores of number of soft/liquid stool, severity of abdominal pain (0 \[none\] to 3 \[Severe\]), general well-being (0 \[well\] to 4 \[terrible\] were summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

The relapse rate was based on confirmed relapses. A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for \> 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of ≥ 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on ≥ two functional system scale scores. Relapse rate was calculated as the total number of relapses divided by the total number of days in the study \* 365.25. ARR was adjusted for region (Eastern Europe vs rest of world), Baseline age, and Baseline number of gadolinium-enhancing lesions; the natural log transformation of time on study was included as an offset term.

A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for \> 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of ≥ 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on ≥ two functional system scale scores. Relapse rate was calculated as the total number of confirmed relapses divided by the total number of days in the study \* 365.25. ARR was based on a Poisson regression model, adjusted for region (Eastern Europe vs Rest of the World), age, and the Baseline number of gadolinium-enhancing lesions, and included the natural log transformation of time on study as an offset term.

Clinical Remission was defined as: Mayo score of \<2 points and with no individual subscore of \> 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. * Stool Frequency Subscore (SFS) * Rectal bleeding Subscore (RBS) * Endoscopy Subscore * Physician's Global Assessment (PGA) Clinical Remission was based on the 4-component Mayo definition.

The cumulative number of total GdE lesions on MRI from Week 12 to Week 24. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.

Measured using the Flavor Profile method of descriptive sensory analysis

Measured using the Flavor Profile method of descriptive sensory analysis

Measured using the Flavor Profile method of descriptive sensory analysis

Measured using the Flavor Profile method of descriptive sensory analysis

AUC from time zero to the last measured time point

Area under the plasma concentration-time curve from time zero extrapolated to infinity

Maximum observed plasma concentration

Minimum observed plasma concentration

Area under the plasma concentration-time curve from time zero to dosing interval

Maximum observed plasma concentration

Area under the concentration-time curve from time 0 to infinity

Area under the concentration-time curve from time 0 to last quantifiable concentration

Maximum observed plasma concentration within the dosing interval

Time to Cmax

Area under the concentration-time curve from time 0 to infinity

Apparent oral clearance

Apparent volume of distribution during terminal phase after oral administration

Terminal elimination half-life

Area under the concentration-time curve from time 0 to time of last quantifiable concentration

Area under the concentration-time curve from time 0 to 14 days postdose

Maximum observed plasma concentration

Area under the concentration-time curve from time 0 to infinity

Area under the concentration-time curve from time 0 to time of last quantifiable concentration

Day 30 maximum time-matched change from Day 29 in systolic blood pressure (SBP)

Maximum observed plasma concentration

Area under the concentration-time curve from time 0 to infinity

Area under the concentration-time curve from time 0 to 14 days post dose